The present invention relates to certain edible, but non-absorbable and non-digestible, polyesters which can be used as fat substitutes in foods and as pharmaceutical compositions. The polyesters herein interfere with the body's absorption of cholesterol and thereby provide a means for treating hypercholesterolemia. It has now been found that these polyesters, while effective for their intended purpose, can undesirably interfere with the body's source of fat-soluble vitamins. By the present invention, the polyesters are fortified with fat-soluble vitamins, thereby avoiding this undesirable effect.
High blood cholesterol (hypercholesterolemia) is recognized as being a risk factor in cardiovascular disease which comprises a major health care problem, today. Epidemiological studies have demonstrated that, with few exceptions, populations consuming large quantities of saturated fat and cholesterol have a relatively high concentration of serum cholesterol and a high mortality rate from coronary heart disease. While it is recognized that other factors can also contribute to the development of cardiovascular disease, there appears to be a causal relationship between the concentration of serum cholesterol, in which hypercholesterolemia results in the accumulation of undesirable amounts of cholesterol in various parts of the circulatory system (atherosclerosis) or in soft tissues (xanthomatosis), and coronary disease and coronary mortality rates.
A variety of dietary and drug regimens have been suggested for alleviating or preventing hypercholesterolemia.
By providing a fat substitute which is non-absorbable and non-digestible, the total content of cholesterol in the body can be lowered. Mineral oil has been suggested both as a fat substitute and as a kind of "intestinal solvent" to dissolve cholesterol and cause its removal in body wastes. However, mineral oil has never been accepted for these uses. Moreover, mineral oil is partially absorbed and undesirably deposits in the liver.
In the present invention, non-absorbable, non-digestible polyesters of sugars (or sugar alcohols) are used as fat substitutes in foods and in unit dose forms as therapeutic compositions. The polyesters herein are fat-like in their physical properties and are excellent fat substitutes for use in foods. Moreover, the sugar polyesters herein efficiently inhibit absorption of cholesterol by the body and, in contrast with mineral oil, are not absorbed and/or deposited in the liver during usage in a treatment/prevention regimen with persons having or likely to develop hypercholesterolemia.
It has now been determined that ingestion of the sugar polyesters herein can interfere with the body's uptake of fat-soluble vitamins. It has also been found that this problem can be overcome by fortifying the polyesters herein, or foods containing said polyesters, with fat-soluble vitamins.